Using Real-World Data for Regulatory Decision-Making
Panel Discussion (301278)
*Li Chen, Amgen
*Nancy Dreyer, IQVIA and UNC Chapel Hill
*Mark Steven Levenson, FDA/CDER
*Tzu-Chieh Lin, Amgen
Keywords: Statisticians, epidemiologists
In this panel discussion, panelists will share their experiences and insight on statistical and operational challenges of implementing the RWE study in regulatory setting.